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 Validation Engineer (JP9302)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Validation Engineer (JP9302)
Location: Thousand Oaks, CA. (Onsite)
Employment Type:  Contract
Business Unit: Superior Systems Engineering
Duration: 1+ years (with likely extensions)
Posting Date:  10/15/2021

3 Key Consulting is hiring a Validation Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Test Method and Validation Engineer.  This position involves support of senior staff in design, development, modification, qualification, validation, and transfer of the test methods for drug delivery combination products and their subassemblies, including drug product containers and packaging components. The particular focus would be on automated dimensional measurements methods, advanced methods for measuring functional attributes of injection systems and enhancing the visual inspection methods. Candidates are expected to have basic engineering skills with a bachelor’s degree in engineering from an accredited university. They are also expected to have strong technical writing skills and be familiar with different engineering measurement techniques and equipment

Why is the Position Open?
Additional workload on team

Top Must-Have Skill Sets:
Engineering measurement
Bachelor’s degree in an engineering field
Technical writing

Day to Day Responsibilities:
• Evaluating and assessing and modifying the existing test method, both their documentation and their implementation in the field.
• Creating new test methods and the required test fixtures.
• Creating a qualification, validation, and transfer plan for the test methods, when required.
• Performing and operating the tests required for qualification, validation and transfer of the methods.
• Creating training documents.
• Conducting the training and creating training reports and other documentations required for qualification, validation and transfer of the test methods.

Basic Qualifications:
Knowledge of statics validations.
1-2 years of hands-on experience.
Master’s degree in mechanical or electrical engineering.
Statistical analysis.
Knowledge of Gage R&R.
Optical and automated measurement devices.
Test method development.
CAD design.
Mechanical modeling.
Manufacturing experience.
IQ, OQ, and PQ.
Performance testing of shipping containers.
Knowledge of primary and secondary packaging.
Teamworking and communication skills.

Employee Value Proposition:
Great biotech/pharma to work for.

Interview process:
Phone screening followed by in-person interview.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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